FDA Approves Pembrolizumab for Stage 3/4a Cervical Cancer

Pembrolizumab (Keytruda) has picked up yet another cancer indication, this time for stage 3-4a cervical cancer in combination with chemoradiation therapy.

The new US Food and Drug Administration (FDA) approval marks the 40th oncology indication for the immunotherapy drug, spanning 19 cancer types, including two previous metastatic cervical cancer approvals.

The new indication is based on an exploratory subgroup analysis from the KEYNOTE-A18 trial, which assessed 596 women with FIGO 2014 stage 3-4a disease.

Participants were randomized equally to receive placebo or pembrolizumab 200 mg every 3 weeks for five cycles with chemoradiation therapy, which included cisplatin weekly for five cycles and external-beam radiation therapy followed by brachytherapy. Placebo or pembrolizumab 400 mg were then continued every 6 weeks for 15 cycles.

At 12 months, progression-free survival was 81% among patients in the pembrolizumab group vs 70% with placebo. Overall, 21% of patients receiving pembrolizumab and 31% receiving placebo experienced a progression-free survival event.

Median progression-free survival was not reached in either arm, and overall survival data were not mature at the time of the analysis.

Among patients receiving pembrolizumab, 10% or more experienced nausea, diarrhea, vomiting, urinary tract infection, fatigue, hypothyroidism, constipation, decreased appetite, weight loss, abdominal pain, pyrexia, hyperthyroidism, dysuria, rash, and pelvic pain.

Pembrolizumab should be administered before chemoradiotherapy when given on the same day, the FDA noted.

M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape. Alex is also an MIT Knight Science Journalism fellow. Email: [email protected]